UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the absorption of neoxanthin into the body
Acronym	Examination of the absorption of neoxanthin into the body
Scientific Title	Examination of the absorption of neoxanthin into the body
Scientific Title:Acronym	Examination of the absorption of neoxanthin into the body
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm whether neoxanthin is absorbed into the body by 28 days continuous intake of baby leaves.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum neoxanthin levels before and after intake of baby leaves for 14 and 28 days.
Key secondary outcomes	Serum levels of beta-carotene and lutein before and after intake of baby leaves for 14 and 28 days.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Baby leaf intake
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Employees of KAGOME Co. Ltd. 2.Who ages more than 20 years old. 3.Who can make self-judgment, voluntarily agreed to participate to this study, and provide written informed consent.
Key exclusion criteria	1.Who have or have a history of serious diseases such as gastrointestinal, diabetes, cardiovascular disease, liver disease, renal disease, or heart disease. 2.Who are pregnant or breast-feeding or willing to be pregnant during this study. 3.Who have allergic to test food. 4.Who have irregular lifestyles (diet, sleep, exercise) 5.Who have a smoking habit 6.Who are taking supplements containing calcium 7.Who have had stones in the past or have been told by a doctor that there is a risk of stones 8.Who have participated in other clinical studies during this study, or willing to be that. 9.Who are judged unsuitable for this study by principal investigator.
Target sample size	14

Research contact person
Name of lead principal investigator	1st name Shigenori Middle name Last name Suzuki
Organization	Kagome Co., Ltd.
Division name	Nature & Wellness Research Department
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Email	Shigenori_Suzuki@kagome.co.jp

Public contact
Name of contact person	1st name Shigenori Middle name Last name Suzuki
Organization	Kagome Co., Ltd.
Division name	Nature & Wellness Research Department
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Homepage URL
Email	Shigenori_Suzuki@kagome.co.jp

Sponsor
Institute	Kagome Co., Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagome Ethics Committee
Address	F tower, Hamacho, Nihonbashi, Tyuo -ku, Tokyo, Japan
Tel	03-5623-8501
Email	Takuji_Hayakawa@kagome.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	カゴメ株式会社（栃木県）

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	14
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 12 Month 04 Day
Date of IRB	2020 Year 11 Month 09 Day
Anticipated trial start date	2019 Year 12 Month 20 Day
Last follow-up date	2020 Year 03 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 20 Day
Last modified on	2021 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049160